Using Dexmedetomidine Prior to Intubation in Neonates

• Status: Recruiting
• Trial end date: 2027-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Neonatal intubations are performed routinely in a NICU. Most intubations are still performed without the administration of medications (awake intubations). Some of the reasons are unavailability of a single good medication, the ease of administration, the physicians comfort level, side effects of medications including apnea, bradycardia, hypotension. Some units use a cocktail of different medications, each with their own side effects We are proposing to study the effects of a single medication, dexmedetomidine (precedex) for the purpose of sedation prior to intubation in neonates.

This study will compare the efficacy of a single dose of dexmedetomidine to controls.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Maimonides Medical Center
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

• neonates

• elective intubation

• admitted to the NICU

• Less than 44 weeks corrected gestational age requiring intubation

Exclusion Criteria:

• babies requiring emergent intubation

• Neonates with birth weight<1250 grams and <1 week of postnatal age

• Neonates with major congenital malformations

• Neonates with preexisting hypotension (MAP < Gest Age)

• Neonates with complex congenital heart disease and heart block